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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
- Source: the test substance is obtained from UCC plant in Texas City , TX (sample no. 48-349)

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.0 - 3.0 kg
- Diet: appropriate commercial diet
- Water: municipal water

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Rabbits were subjected to 24 hours of contact with the test material which is retained under impervious sheeting on the clipped, intact skin of the trunk. As necessary for larger doses, gauze is wrapped around the trunk over the sample to prevent leakage. Vetrap® Bandaging Tape is wrapped over the impervious sheeting and the animal is returned to its cage for the contact period.
Duration of exposure:
24 h
Doses:
16 mL/kg
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
After the contact period, excess fluid is removed to diminish ingestion. Observations for skin reaction are made at one hour, 7 days and 14 days after the contact period. Five male and 5 females are included on each level used for the LD50 calculation. Animal weights are recorded at 0 days (before dose), 7 days and 14 days (just prior to sacrifice). At death or sacrifice, each animal is subjected to gross pathologic evaluation.
Statistics:
LD50's and the estimated LD50 slopes are calculated by the moving average method (Thompson, 1947; Weil, 1983) and are based on a 14-day observation period.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 16 mL/kg bw
Based on:
test mat.
Remarks on result:
other: Equivalent to >18000 mg/kg bw
Mortality:
None
Clinical signs:
In male rabbits, sample residue and oedema were observed at day 1. In females rabbits, sample residue, oedema and erythema where observed on day 1.
Body weight:
Male and female rabbits gained weight during the 14 day observation period (See 'Any other information on results incl. tables').
Gross pathology:
There were no treatment related gross pathologic observations in male or female rabbits.

Any other information on results incl. tables

Table: Male and female rabbit body weights following a 24 hour dermal exposure to the test substance

 

Day 0

Day 7

Day 14

Males

2679 ± 270

2743 ± 342

2846 ± 344

Females

2775 ± 174

2820 ± 204

3011 ± 224

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met

Route: .live2